Challenges in Moving Toward Product Development

Publisher Summary This chapter briefly describes the product development process for implantable neurostimulation devices. Implantable stimulators are used for a variety of applications, beginning initially with cardiac pacing, and progressing through the applications of suppression of chronic pain, restoration of hearing, control of urinary incontinence, and suppression of the symptoms of Parkinson's disease and other movement disorders such as cerebral palsy, dystonia, and epilepsy. Product identification and market analysis are extremely important activities as a careful review of the market can determine whether an existing market is being underserved, or f a nonexisting market may be developed. In the initial product identification process, the business benefits should be identified, a milestone schedule is prepared, staffing and resource requirements are determined and risk areas (business, technical, clinical) are considered. A feasibility study can be a very important step in the product development, as it can determine whether any unresolved risks may or may not be mitigated by design changes. The result of the product identification and market analysis leads directly to the development of a list of marketing requirements, the product specifications and functions that are directly tied to customer needs and the intended uses. The functional or product specification is the top level technical product requirements document, which is drawn directly from the marketing requirements. Every feature of the product should have a traceable requirement and function so that the development of the product can be tracked and all features and functions realized in the final form of the system. Basic functional diagrams for each element may be defined with the interfaces to other elements so that project partition and team building may occur and be monitored. Then the process of design phase starts in which the essential design of the product development is carried out, using the information gathered in the feasibility studies and the marketing specification, functional specification, and architectural description.